AB0451 FRENCH REAL LIFE SAFETY DATA ON THE USE OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONAL STUDY, DEFACTO
Authors: C. Gaujoux-Viala, A. Basch, S. Lassoued, F. Coury-Lucas, M. Kessouri, Y. Brault, T. Lequerre, C. Salliot
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Tofacitinib, an oral Janus Kinase inhibitor, is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA). <h3>Objectives</h3> To describe the safety profile of Tofacitinib in a French prospective observational study DeFacTo. <h3>Methods</h3> The safety profile of tofacitinib was assessed using interim data from a descriptive analysis of patients who took at least one dose of tofacitinib in the DeFacTo study. <h3>Results</h3> Among 314 patients enrolled in the study, 306 received tofacitinib and were included in the safety analysis, including 274 patients with a follow-up ≥ 18 months (POP2) on 03/15/22 date of analysis) with a median exposure duration of 538 [Q1; Q3: 381; 554] days. 113 patients (41.2%) were still on tofacitinib (39 discontinued, 122 missing data regarding prescription). At inclusion, 78.3% of the 306 pts were women with a mean (± standard deviation) age of 59.5 ± 11.5 years, median disease duration of 8.9 years [Q1; Q3: 4.1; 18.9]. There was a history of cardiovascular (CV) disease in 11.9% of cases (including 4.6% myocardial infarction (MI), 5.0% stroke/transient ischemic attack (TIA), 1.7% heart failure, and 1.7% peripheral arterial disease); 5.6% history of cancer, 16.8% history of infection, and 46.6% smoker/former smoker. Tofacitinib was prescribed in combination with a csDMARD in 61.1% of patients and corticosteroids in 56.2% of cases. The results showed that adverse events (AEs) were reported in 54.2% of the 306 patients, 14.4% were considered as serious. Infections were found in 22.2% of patients, no deaths were reported (Table 1). <h3>Conclusion</h3> These intermediate, descriptive results show a safety profile of tofacitinib in real-life RA similar to the one previously reported in clinical and observational studies. <sup>[1-2]</sup> <h3>References</h3> [1]Wollenhaupt et al. Arthritis Research &amp; Therapy (2019) 21:89 https://doi.org/10.1186/s13075-019-1866-2 [2]Kremer et al. ACR Open Rheumatology 2021. DOI 10.1002/acr2.11232 <h3>Acknowledgements</h3> This study was sponsored by Pfizer. <h3>Disclosure of Interests</h3> Cécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Shareholder of: Pfizer, Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer.